ORICULT DTM— 510(k) K802947

Substantially Equivalent

Orion Diagnostica, Inc.

FDA 510(k) clearance K802947 for ORICULT DTM, Substantially Equivalent on 1980-12-22. Applicant: Orion Diagnostica, Inc.. Device class: 1.

Clearance details

Applicant: Orion Diagnostica, Inc.
Product code: Code JSI
Device class: Class 1
Regulation: 21 CFR 866.2360
Advisory panel: Microbiology
Date received: 1980-11-19
Decision date: 1980-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.